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Smiths Medical Portex® BLUselect® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients.

Smiths Medical Portex® BLUselect® Suctionaid® Tracheostomy Tube is indicated for airway maintenance of tracheostomised patients. Suctionaid® allows aspiration of contaminated mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.

The BLUselect® Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect® Tracheostomy Tube indicated for airway maintenance of tracheostomy patients.

The Smiths Medical Portex® BLUselect and BLUselect Suctionaid Tracheostomy Tubes are designed to aid the adult population who require an artificial airway due to trauma or medical condition. Patients who benefit from this procedure are those who: require prolonged intubation for mechanical ventilator support; cannot manage their airway secretions; or have an upper airway obstruction. BLUselect Inner Cannula is intended to be used with the Smiths Medical Portex® BLUselect Tracheostomy Tubes. The subject device package consists of a tracheostomy tube, a tube holder, cleaning brush, an inner cannula, obturator, disconnection wedge, and a vacuum control valve (with Suctionaid® tubes only) and a maximum recommended period of use is 29 days; intended to be used critical care settings, acute care settings, long term care facilities, and for home use.

The tube is manufactured with a flange, inflation line, suction line and a 15mm connector. All components are manufactured from medical grade materials and have biocompatibility data for safe use when in-contact with patient tissue/bodily fluids/secretions.

This document, K173384, is a 510(k) Summary for medical tracheostomy tubes and inner cannulas. It asserts substantial equivalence to predicate devices, focusing on design, materials, and performance testing rather than clinical study data with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent if it meets the criteria of the predicate device and relevant international standards. The criteria are based on physical and functional characteristics, and the reported performance indicates compliance with these.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for specific tests. The tests were bench tests conducted on the physical device components. Data provenance would be from internal laboratory testing at Smiths Medical. The tests are non-clinical, so country of origin of patient data or retrospective/prospective is not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for performance was established through compliance with recognized international standards (ISO, ASTM) and FDA guidance for medical device testing, rather than expert consensus on a test set of cases.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human assessment or adjudication of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This submission is for a physical medical device (tracheostomy tube), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is objective compliance with established performance standards (ISO 5366, ISO 5356-1, ISO 18190, ASTM F2052-15, ASTM F2503), FDA guidance (e.g., for cleaning validation), and biocompatibility standards (ISO 10993-1). There is no clinical ground truth (e.g., pathology, outcomes data) as this is a premarket notification based on substantial equivalence to predicate devices and non-clinical testing.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model. Therefore, there is no training set involved.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

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CADD®- Solis Ambulatory Infusion Pump with Wireless Communication

CADD®-Solis Infusion Pump, Model 2110
The CADD®-Solis Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space. The pump is intended for therapies that require a continuous rate of infermittent bolus, and/or with patientcontrolled demand doses.

PharmGuard® Administrator Medication Safety Software
The PharmGuard® Administrator Medication Safety Software allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis Infusion Pump.

CADD® Administration Set
The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container.

Wireless Communication Module (CM)
The Wireless Communication Module is intended to be used as an accessory to provide wireless capability and battery power to a CADD®-Solis Infusion Pump, Model 2110

The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, work together to provide wireless communication between the pump and the server and are similar to currently marketed products.

The CADD®-Solis Infusion Pump, Model 2110 has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 3.0 (K130394). The user activates CADD®-Solis Infusion Pump, Model 2110 via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container. The Flow Stop feature is a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The Flow Stop is located on the set housing, which is attached to the pump.

The provided text is a 510(k) summary for the CADD®-Solis Ambulatory Infusion Pump with Wireless Communication. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific, novel acceptance criteria through a dedicated study with statistical endpoints. Therefore, many of the requested categories for a rigorous clinical or performance study involving AI or human readers are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the performance testing and how the device's modifications are verified.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific acceptance criteria with corresponding performance metrics in a quantitative manner as one might expect from a statistically powered study. Instead, it states that "All the testing met the acceptance criteria." and "Device testing met pre-defined acceptance criteria and did not raise new or different question of safety or effectiveness." The criteria are largely described by adherence to relevant standards and a safety assurance case.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of a statistical study with a defined sample size (e.g., number of patients or cases). The testing performed is described as "non-clinical performance testing," "design verification and validation testing," and "software testing." Provenance is not applicable to this type of testing (e.g., no patient data is mentioned).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a 510(k) submission for an infusion pump and its accessories, not an AI/diagnostic device that relies on expert interpretation of data to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI diagnostic tool and does not employ "human readers" in the context of interpreting medical images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself (the infusion pump system and its software/accessories) in delivering medication and communicating data. The non-clinical performance testing, design verification, and validation studies serve this purpose. The document states that these tests demonstrate "the device is substantially equivalent to the legally marketed predicate device."

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering specifications and design inputs: The device is tested against its own design requirements.
• Industry standards: Compliance with standards like IEC 60601-1, IEC 62304, ISO 10993-1, etc.
• Predicate device characteristics: The new device's performance characteristics are compared to those of the legally marketed predicate devices (K130394 and K040636) to demonstrate substantial equivalence.
• GLP (Good Laboratory Practice) pre-clinical studies: For the new intrathecal indication of the administration sets, studies were conducted to show freedom from unacceptable neurotoxicological risk.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as #8.

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